MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.8MM DIA DRILL BIT 16MM STOP LGTH 23MM FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number	03.505.086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dzj.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed as no product was received.Device is not distributed in the united states but is similar to device marketed in the usa.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a ssro surgery on (b)(6) 2019, the 2 drill bits (03.505.086) were broken when drilling left side after the right.The surgery was completed and there was no harm to the patient.It was unknown whether there was a surgical delay or not.Concomitant device reported: unknown hand piece (part # unknown, lot # unknown, quantity 1).This is report 1 of 2 for (b)(4).

• Brand Name: 1.8MM DIA DRILL BIT 16MM STOP LGTH 23MM FOR 90° SCREWDRIVER
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9498201
• Report Number: 8030965-2019-71284
• Device Sequence Number: 2981949
• Product Code: DZI
• UDI-Device Identifier: 10887587013688
• UDI-Public: (01)10887587013688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.505.086
• Device Catalogue Number: 03.505.086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1